Stertilization pouch with internal and external indicators

Abstract

A sterilization package includes a first package layer and a second package layer coupled to the first package layer with a perimeter seal extending around a portion of the sterilization package to define a pouch having a proximal end and a distal end. A first sterilization indicium is disposed on the second package layer exterior of the pouch and a second sterilization indicium is disposed on the second package layer interior of the pouch. The first and second sterilization indicia are multi-parameter sterilization indicia configured to be responsive to a sterilization process such that the first and second sterilization indicia undergo a visual change to a desired ending color when the package is subjected to complete multi-parameter sterilization conditions.

What is claimed is: 
     
       1. A method for making a sterilization package, the method comprising: printing a plurality of sterilization indicia on a first major side of a paper layer, the plurality of sterilization indicia including first, second, third and fourth multi-parameter sterilization indicia configured to be responsive to a sterilization process such that the first, second, third and fourth multi-parameter sterilization indicia undergo a visual change to a desired ending color when the sterilization package is subjected to complete multi-parameter sterilization conditions; bonding a polymer layer to the first major side of the paper layer with a perimeter seal, the perimeter seal extending around a portion of the sterilization package to define a pouch having a proximal end with a sealable opening and a distal end; bonding a release layer to the first major side of the paper layer, wherein the perimeter seal is disposed between the first and second multi-parameter sterilization indicia and between the third and fourth multi-parameter sterilization indicia at the distal end of the pouch and the sterilization package includes a first barrier seal and a second barrier seal, the first barrier seal and the second barrier seal disposed adjacent to the second and fourth multi-parameter sterilization indicia respectively, and each barrier seal separated from the perimeter seal. 
     
     
       2. The method of  claim 1 , wherein the first and the second multi-parameter sterilization indicia are configured to be responsive to a steam sterilization process. 
     
     
       3. The method of  claim 1 , wherein the third and the fourth multi-parameter sterilization indicia are configured to be responsive to a gas sterilization process. 
     
     
       4. The method of  claim 3 , wherein the third and the fourth multi-parameter sterilization indicia are configured to be responsive to ethylene oxide. 
     
     
       5. The method of  claim 3 , wherein the first major side of the paper layer comprises a region configured to bond with the release layer. 
     
     
       6. The method of  claim 5 , wherein the first major side of the paper layer comprises a fold line separating the region and the perimeter seal.